classification Accelerator, Linear, Medical Manufacturer:

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gudid Pelvis Belly Replacement Stomach Cushion - Small Manufacturer: Bionix, LLC

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gudid Pelvis Belly Replacement Face Cushion Assembly Manufacturer: Bionix, LLC

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gudid Pelvis Belly Replacement Stomach Cushion - Medium Manufacturer: Bionix, LLC

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gudid Pelvis Belly Replacement Arm Rest Cushion Manufacturer: Bionix, LLC

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gudid Pelvis Belly Replacement Leg Cushion Manufacturer: Bionix, LLC

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gudid Prone Breast, Hardware Kit, Head Rest Carriage, Replacement Manufacturer: Bionix, LLC

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gudid Prone Breast, Hardware Kit, Head Rest Push Button Assembly, Replacement Manufacturer: Bionix, LLC

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gudid Prone Breast, Hardware Kit, Threaded Indexing Pegs Manufacturer: Bionix, LLC

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gudid Prone Breast, Hand Post Assembly, Replacement Manufacturer: Bionix, LLC

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gudid Prone Breast, Leg Cushion, Replacement Manufacturer: Bionix, LLC

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gudid Prone Breast, Arm Rest, Replacement Manufacturer: Bionix, LLC

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gudid Prone Breast, Face Cushion, Replacement Manufacturer: Bionix, LLC

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gudid Prone Breast, Cushion, Contralateral Breast Insert, 15 degree, Replacement Manufacturer: Bionix, LLC

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gudid Prone Breast, Breast Bridge, Small Opening, Replacement Manufacturer: Bionix, LLC

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gudid SecureVac Cushion, Wing Board w/ Head Rest, 100CM X 60CM, 15L Manufacturer: Bionix, LLC

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gudid SecureVac Cushion, Wing Board, 100CM X 60CM, 15L Manufacturer: Bionix, LLC

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gudid SecureFoam - SAMPLE Large Box Manufacturer: Bionix, LLC

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gudid SecureFoam - SAMPLE Medium Manufacturer: Bionix, LLC

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gudid SecureFoam - SAMPLE Small Manufacturer: Bionix, LLC

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gudid SecureFoam, Large, Component A Manufacturer: Bionix, LLC

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gudid SecureFoam, Medium, Component A Manufacturer: Bionix, LLC

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gudid SecureFoam, Small, Component A Manufacturer: Bionix, LLC

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gudid Sample, SecureFoam - Pouch-Pro, Medium Manufacturer: Bionix, LLC

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gudid Multi-Treatment Base Manufacturer: Bionix, LLC

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gudid Prone Breast Bridge: Large Manufacturer: Bionix, LLC

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gudid Prone Breast: Baseless Treatment System Manufacturer: Bionix, LLC

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gudid TruGuard, Standard Manufacturer: Bionix, LLC

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gudid Pelvis Belly, Large Stomach Cushion Manufacturer: Bionix, LLC

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gudid Pelvis Belly Pad Set Manufacturer: Bionix, LLC

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gudid SecureVac Cushion 100CM X 100CM, 50L Fill Manufacturer: Bionix, LLC

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gudid SecureVac Cushion 70CM X 50CM, 15L Fill Manufacturer: Bionix, LLC

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gudid SecureVac Cushion 70CM X 70CM, 20L Fill Manufacturer: Bionix, LLC

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gudid SecureVac Cushion 115CM X 114CM, 35L Fill Manufacturer: Bionix, LLC

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gudid SecureVac Cushion 115CM X 114CM, 25L Fill Manufacturer: Bionix, LLC

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gudid SecureVac Cushion, T-Vac Manufacturer: Bionix, LLC

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gudid SecureVac Cushion, TriVac Manufacturer: Bionix, LLC

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gudid SecureVac Cushion 100CM X 70CM, 35L Fill Manufacturer: Bionix, LLC

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gudid SecureVac Cushion 150CM X 100CM, 80L Fill Manufacturer: Bionix, LLC

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gudid SecureVac Cushion 80CM X 150CM, 70L Fill Manufacturer: Bionix, LLC

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gudid SecureVac Cushion 80CM X 150CM, 55L Fill Manufacturer: Bionix, LLC

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gudid SecureVac Cushion 80CM X 150CM, 47L Fill Manufacturer: Bionix, LLC

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gudid SecureVac Cushion 80CM X 150CM, 35L Fill Manufacturer: Bionix, LLC

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gudid SecureVac Cushion 150CM X 70CM, 55L Fill Manufacturer: Bionix, LLC

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gudid T-Form SecureVac Box Adaptor Manufacturer: Bionix, LLC

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gudid SecureFoam - Pouch-Pro, Medium, Box Label Manufacturer: Bionix, LLC

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gudid LIAC HWL Manufacturer: S.I.T. SORDINA IORT TECHNOLOGIES SPA

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gudid LIAC HWL Manufacturer: S.I.T. SORDINA IORT TECHNOLOGIES SPA

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gudid The NOVAC 11 is an electron linear accelerator used for radiation therapy duringsurgical procedures in an operating room for the treatment of malignant and benignconditions. Known as Intraoperative Radiation Therapy (IORT), this technique allowsdelivery of high doses of radiation directly aimed at tumors or other sites while avoidingdosage to surgically mobilized normal tissues.The NOVAC 11 is a mobile and articulated machine that can be moved towards thepatient and put in the appropriate position to carry out the necessary radiotherapy. Manufacturer: S.I.T. SORDINA IORT TECHNOLOGIES SPA

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gudid The absorber shields are discs used to radioprotect the patients organs. They shall be inserted below the tissue treated during the surgery. They can be inserted within the surgical incision. Manufacturer: S.I.T. SORDINA IORT TECHNOLOGIES SPA

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gudid The absorber shields are discs used to radioprotect the patients organs. They shall be inserted below the tissue treated during the surgery. They can be inserted within the surgical incision. Manufacturer: S.I.T. SORDINA IORT TECHNOLOGIES SPA

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gudid The absorber shields are discs used to radioprotect the patients organs. They shall be inserted below the tissue treated during the surgery. They can be inserted within the surgical incision. Manufacturer: S.I.T. SORDINA IORT TECHNOLOGIES SPA

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gudid The absorber shields are discs used to radioprotect the patients organs. They shall be inserted below the tissue treated during the surgery. They can be inserted within the surgical incision. Manufacturer: S.I.T. SORDINA IORT TECHNOLOGIES SPA

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gudid The absorber shields are discs used to radioprotect the patients organs. They shall beinserted below the tissue treated during the surgery. They can be inserted within the surgicalincision. Manufacturer: S.I.T. SORDINA IORT TECHNOLOGIES SPA

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gudid The absorber shields are discs used to radioprotect the patients organs . They shall beinserted below the tissue treated during the surgery. They can be inserted within the surgicalincision. Manufacturer: S.I.T. SORDINA IORT TECHNOLOGIES SPA

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gudid LIAC is intended for use in radiation therapy in the operating theatre on a patient from whom the surgeon has just removed a neoplasia.The device may solely be used for oncological radiation therapy. The contraindications are related to use on non-oncological patients.To this end, the mobile structure with its equipment is moved to the patient at the appropriate time and placed in a position such that the applicator can be connected.At this point, the operating theatre is evacuated and the radiation command given from the console outside, after which the mobile structure is removed and surgery completed.The radiation time is normally not more than two minutes and therefore does not significantly affect the surgery time. The machine may only be used by radiation therapy or surgery staff previously trained for its use.In order to reduce the dose to the healthy tissues of the patient during the therapeutic treatment, the specific Abdominal Radiation Protection Screens must be used. The control console normally does not require sterilization but only regular cleaning.LIAC is intended to be used in a public and private health environment.LIAC is intended to be handled by trained personnel (operators)authorised by the user (authority responsible). Manufacturer: S.I.T. SORDINA IORT TECHNOLOGIES SPA

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gudid LIAC is intended for use in radiation therapy in the operating theatre on a patient from whom the surgeon has just removed a neoplasia.The device may solely be used for oncological radiation therapy. The contraindications are related to use on non-oncological patients.To this end, the mobile structure with its equipment is moved to the patient at the appropriate time and placed in a position such that the applicator can be connected.At this point, the operating theatre is evacuated and the radiation command given from the console outside, after which the mobile structure is removed and surgery completed.The radiation time is normally not more than two minutes and therefore does not significantly affect the surgery time. The machine may only be used by radiation therapy or surgery staff previously trained for its use.In order to reduce the dose to the healthy tissues of the patient during the therapeutic treatment, the specific Abdominal Radiation Protection Screens must be used. The control console normally does not require sterilization but only regular cleaning.LIAC is intended to be used in a public and private health environment.LIAC is intended to be handled by trained personnel (operators)authorised by the user (authority responsible). Manufacturer: S.I.T. SORDINA IORT TECHNOLOGIES SPA

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gudid 1.10mm x 3.0cm VISICOIL loaded in an 17 gauge brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 1.10mm x 2.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 1.10mm x 2.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 1.10mm x 1.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 1.10mm x 1.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 1.10mm x 0.5cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.75mm x 3.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.75mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.75mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.75mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.75mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.75mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.75mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.75mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.75mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.75mm x 0.50cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.50mm x 2.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.5mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.5mm x 1.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.5mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.50mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.50mm x 0.5cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.50mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.50mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.35mm x 4.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.35mm x 3.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.35mm x 2.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.35mm x 1.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.35mm x 0.5cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.5mm x 2cm Platinum Fiducial MarkerPre-Loaded Needle 21g x 20cm Manufacturer: Izi Medical Products, LLC

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gudid 0.50mm x 2cm Platinum Fiducial MarkerPre-Loaded Needle 21g x 15cm Manufacturer: Izi Medical Products, LLC

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gudid 0.5mm x 2cm Platinum Fiducial MarkerPre-Loaded Needle 21g x 08cm Manufacturer: Izi Medical Products, LLC

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gudid 0.50mm x 0.5cm VISICOIL MR Platinum loaded in an 21 gauge 20cm pre-waxed needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.50mm x 01.0cm VISICOIL MR Platinum loaded in a 21 gauge 15cm pre-waxed needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.5mm x 1cm Platinum Fiducial MarkerPre-Loaded Needle 21g x 08cm Manufacturer: Izi Medical Products, LLC

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gudid 0.50mm x 0.5cm VISICOIL MR Platinum loaded in an 21 gauge 15cm pre-waxed needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.50mm x 0.5cm VISICOIL MR Platinum loaded in an 21 gauge 8cm pre-waxed needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.35mm x 3.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.35mm x 2.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.35mm x 2.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachytherapy needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.35mm x 2.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 8cm needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.35mm x 0.5cm VISICOIL MR Platinum loaded into an 22g 20cm pre-waxed needle. Manufacturer: Izi Medical Products, LLC

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gudid 0.35mm x 0.5cm VISICOIL MR Platinum loaded into an 22g 15cm pre-waxed needle. Manufacturer: Izi Medical Products, LLC

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FDA Product Code: IYE